The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

Not Applicable

Completed

• Conditions: Hand Burn
• Interventions: Other: Extracorporeal shock wave therapy

• Registration Number: NCT04138355
• Lead Sponsor: Hangang Sacred Heart Hospital

Brief Summary

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

Detailed Description

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-11-02
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-20
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands
• less than 6 months since the onset of the burn injury

Exclusion Criteria

• fourth-degree burns(involving muscles, tendons, and bone injuries)\
• musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands
• neurological diseases(such as peripheral nerve disorders)
• preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)
• severe pain impeding hand rehabilitation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy group	Extracorporeal shock wave therapy	. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.

Primary Outcome Measures

Name	Time	Method
transepithelial water loss	4 weeks	the degree of water evaporation
elasticity	4 weeks	The numeric values (mm) of the skin's distortion is presented as the elasticity.
thickness	4 weeks	scar thickness(cm)
sebum	4 weeks	the severity of greese, the higher values indicating a more greese(mg/cm2)
melanin and erythema	4 weeks	measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)

Secondary Outcome Measures

Name	Time	Method
grip strength	4 weeks	measure grip strength, the higher values indicating a more strength
Jebsen-Taylor hand function test	4 weeks	The JTT measure the performance speed of standardized tasks. The JTT involves a series of 7 subtests. We used a scoring system (each subtest score ranged from 0 to 15, and the total score ranged from 0 to 105).

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Yeong-deungpo-Dong, Korea, Republic of